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AESKULISA Cardiolipin-AGM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA, IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein | which are only expressed when ß2-glycoprotein | interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

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I am sorry, but based on the provided document, there is no information about acceptance criteria, a study proving device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document contains:

• A letter from the FDA to Aesku. Inc regarding their 510(k) premarket notification for AESKULISA® Cardiolipin.
• Indications for Use statements for several AESKULISA® Cardiolipin products (AGM, A, GM, Check).

These sections describe the device, its intended use (detection of IgA, IgG, and/or IgM antibodies against cardiolipin to aid in the diagnosis of SLE, primary and secondary APS), and the FDA's determination of substantial equivalence to previously marketed devices. However, they do not include any technical study details or performance metrics.

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